Atypical antipsychotics - "off label" marketing and mega claims with US pharma companies

Lord Patel's favourite Republican Senator, Charles "Chuck" Grassley fresh from exposing the high living high spending at the Smithsonian is at it again.

This time he has written a letter which he has copied to us ;

Sidney Taurel
Chairman and Chief Executive Officer
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, IN 46285

Dear Mr. Taurel:

As a senior member of the United States Senate and as Ranking Member of the Committee on Finance (Committee), I have an obligation to ensure that the public’s money is properly spent to provide safe and effective treatments to the vulnerable populations that are beneficiaries of the Medicare and Medicaid programs.

I am aware of several pending products liability actions regarding Zyprexa, an anti-psychotic drug manufactured by Eli Lilly and Company (Eli Lilly). Specifically, questions have been raised regarding safety information and marketing practices relating to that drug. Furthermore, I understand that Eli Lilly produced certain ocuments in the course of these litigations that shed light on issues of interest to the Committee.

On December 20, 2006, I wrote to Dr. David Egilman, a plaintiffs’ expert, to request information and documents related to Zyprexa. Dr. Egilman did not provide any confidential Eli Lilly documents regarding Zyprexa. Instead, Dr. Egilman responded to my request by providing the Committee with a copy of a discovery order, dated December 15, 2006, instructing him to return Eli Lilly documents in his possession to Richard D. Meadow of the Lanier Law Firm. Eli Lilly had alleged that some of its confidential documents had been disseminated without the company’s authorization. Although
no one affiliated with the Committee was a party to that dispute, I decided to suspend efforts to obtain the relevant documents until that dispute was resolved.

On February 14, 2007, Judge Jack Weinstein of the U.S. District Court for the Eastern District of New York issued a decision regarding the confidential Eli Lilly documents. The court enjoined several individuals from further disseminating the protected documents and ordered them to return any such documents and copies still in their possession or control. Contrary to what was reported in Judge Weinstein’s decision, the Committee’s Chief Investigative Counsel, Emilia DiSanto, did not receive any protected documents related to Zyprexa from Mr. James Gottstein or Dr. Egilman. Nor did Mr. Gottstein or Dr. Egilman provide any protected documents related to Zyprexa to other Committee staff.

As the dispute regarding the dissemination of the documents is now resolved, I believe the time is now right for the Committee to pursue its request for the documents. I am writing to request your cooperation with the Committee’s inquiry. In that regard please provide to the Committee all documents and materials, including, but not limited to, emails, letters, reports, and memoranda, that were made available to thecourt-appointed Plaintiffs’ Steering Committee I and II pursuant to pretrial discovery in In re Zyprexa Prods. Liab. Litig.

Thank you in advance for assisting the Committee. I would appreciate receiving the requested documents in an electronic and searchable format by no later than April 25, 2007.

Sincerely,
Charles E. Grassley
United States Senator

Writes a sharp but informative letter Chuck - this relates to newspaper stories that Lilly "downplayed safety risks and engaged in other improper marketing practices that may be jeopardizing patients’ health."

In December, the New York Times had claimed that Lilly had told its sales representatives to play down data showing 30 percent of patients taking Zyprexa gained 22 pounds (10Kg)or more after a year on the drug, with some reporting gains of 100 (50Kg) pounds or more.

Indianapolis-based Lilly have had claims from 7 states, including 2 this year - one from Montana recently filed and reported. (Montana v. Eli Lilly & Co., No. ADV-2007-188, 1st Judicial District Court, Lewis & Clark County, Montana.)

Lilly allegedly gave kickbacks to doctors and improperly promoted the drug to nursing homes as a sedative,... bought off a disgruntled'' sales director to keep him from disclosing its marketing practices... instructed its representatives to minimize and misrepresent the dangers of Zyprexa, affirmatively and consciously placing company profits above the public safety,'' according to the complaint. "This failure to warn was designed and intended to maximize company profits.''

Under Federal law, doctors can prescribe medications for uses that aren't approved by the U.S. Food and Drug Administration (FDA) , although pharmaceutical companies are barred from marketing their drugs for such "off-label'' uses. The Montana complaint says Lilly created a 280-person sales force "to promote Zyprexa exclusively for off-label uses, specifically for long term care facilities to maximize off-label use of Zyprexa sales' for the elderly"

Lilly are not alone . AstraZeneca Plc's Seroquel and Johnson & Johnson's Risperdal, all members of a class of medications called atypical antipsychotics, have been linked to weight gain and diabetes. In September 2003, the FDA required the three companies to place warnings on the drugs' labels.

The three drugs, approved for schizophrenia and bipolar disorder, are among the top-selling medications in the world. Lilly's global sales of Zyprexa were $4.36 billion in 2006, Risperdal sales were $4.18 billion and Seroquel's worldwide sales in 2006 were $3.4 billion. It is claimed that as many as half of the prescriptions for the three drugs are for off-label use.

So far Lilly states in regulatory filings for the SEC that they have settled about 28,500 claims brought by users of Zyprexa for a total of as much as $1.2 billion. About 1,300 individual claims remain pending, the company.

Lilly recently merged with Icos Corp , makers of Cialis whose sales reached 35.6% of aggregate market share (Levitra and Viagra make up the rest) for erectile dysfunction products which has just been launched in China. Word is on the street that the Lilly product provides a bigger boner for longer. Lilly recently issued US$2.5 Bn Bonds (Aa3 Moody's AA s&P) to repay debt used in its acquisition of drugmaker Icos Corp., - its biggest bond sale ever... which is ..er ... appropriate.